MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2200-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Administrative secretary materials management, materials resource utilization coordinator.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer had reported separation at the lower fitment.The customer later reported that in the nicu, approximately 50 minutes after the tubing was changed the device alarmed for air in line.The tubing was clamped, and the set was removed from the pump module.The silicone portion of the set was tapped to dispel any air bubbles, and when this was done, the tubing below the pump segment separated.There was a free flow of fluid from the set.The portion of tubing that was still attached to the infant was clamped.Iv fluid and tubing were replaced.The customer questions if the set came unglued.There was no report of patient harm.
Event or Problem Description
The customer had reported separation at the lower fitment.The customer later reported that in the nicu, approximately 50 minutes after the tubing was changed the device alarmed for air in line.The tubing was clamped, and the set was removed from the pump module.The silicone portion of the set was tapped to dispel any air bubbles, and when this was done, the tubing below the pump segment separated.There was a free flow of fluid from the set.The portion of tubing that was still attached to the infant was clamped.Iv fluid and tubing were replaced.The customer questions if the set came unglued.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the set separated at the lower fitment was confirmed.Visual inspection showed that the silicone segment was completely separated from the lower fitment.The expected retainer ring for the lower fitment and silicone segment connection was not received.No crush marks were observed on the upper fitment.Further visual inspection of the separation showed o-ring indentations on the silicone segment.The separated silicone was manually reassembled and fully reseated by hand.Functional and pressure testing was performed; no leaks or issues were observed.The root cause of the tubing separation is customer misuse involving the set being stretched or flicked when attempting to get the air out of the line.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8090103
• Report Number: 9616066-2018-02302
• Device Sequence Number: 1684604
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015, THERAPY DATE (B)(6) 2018
• Patient Age: 2 DA